TEENCOPE: An Internet Coping Skills Training Program for Teens With Type 1 Diabetes

An Internet Coping Skills Training Program for Teens With Type 1 Diabetes

The purpose of the study is to compare the effects of a 5-week internet-based coping skills training program (TeenCope) with a 5-week internet education program (Managing Diabetes) in youth (age 11-14) with type 1 diabetes on intensive insulin therapy.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: TeenCope; Behavioral: Managing Diabetes

Detailed Description

It is well established that for many youth with type 1 diabetes (T1D), the developmental stage of puberty is characterized by a significant deterioration in metabolic control. Previous research conducted by the Yale School of Nursing demonstrates that providing cognitive-behavioral coping skills training program (CST) as a supplement to intensive medical treatment regimen enhances physiological and psychosocial outcomes - most notably in youth as they approach adolescence. Successful CST programs studied at Yale consist of weekly, in-person group sessions over a 5-week period conducted by a clinical psychologist or social worker.

Rapid advances in technology have made the internet a compelling tool to reach out to youth and significantly broaden the application of CST programs. Investigators at Yale (scientists, NPs, clinical psychologists) have teamed with web specialists (computer programmers, web designers, graphic artists, and illustrators) and youth with T1D and their parents to adapt the successful CST program for use on the internet. In this trial, internet-based CST (TeenCope) will be evaluated by comparing it to an internet-based education program for managing diabetes (Managing Diabetes).

Three hundred (300) youth from 4 different sites within the U.S will take part in the study. Youth will be randomly assigned to complete either the TeenCope or Managing Diabetes program right away, and will be given the opportunity to complete the alternate program after 12 months. Data on psychosocial and disease management parameters will be collected at baseline, 3, 6, 12 and 18 months through youth filling out online questionnaires (lasting approximately 30 minutes). Clinical outcome data (height, weight, HbA1c, episodes of hypoglycemia, DKA, and hospitalization) will be collected from the medical chart throughout the study, and parents will complete a demographic data form.

This study has great potential for working with youth with type 1 diabetes. If proven effective, the investigators are interested in continued dissemination and translation of this intervention beyond their geographical location.

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University School of Nursing
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 11-14
• English speaking
• Youth assents and parent consents to participation
• School grade is appropriate to age within 1 year
• Type 1 diabetes for a minimum of 6 months
• Access to high speed internet service for 5 week intervention (will be arranged by study if not presently in the home)

Exclusion Criteria:

• Other significant chronic health problems requiring intensive self-management
• Previous exposure to Yale School of Nursing's Coping Skills Training or Managing Diabetes materials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; TeenCope: Internet-based Coping Skills Training	Behavioral: TeenCope; Teencope consists of a series of 5 sessions designed to increase children's sense of competence and mastery by retraining inappropriate or non-constructive coping styles and forming more positive styles and patterns of behavior. Each week a new 30-45 minute session is uploaded to a password-protected website on the Yale server for youth to complete. Youth are grouped with 8-12 peers who complete the same weekly sessions in an asynchronous manner. Youth interact with each other on an online discussion board moderated by a clinical psychologist
ACTIVE_COMPARATOR: 2; Managing Diabetes: Internet-based Diabetes Education	Behavioral: Managing Diabetes; Managing Diabetes consists of 5 sessions on educational content related to diabetes self management targeted to adolescents. As with the TeenCope program, each week a new 30-45 minute session is uploaded to a password-protected website on the Yale server for youth to complete. Youth complete educational sessions independently over 5 weeks. There is no online discussion board or peer interaction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin A1c (HbA1c)	18 months
Pediatric Quality of Life Inventory (PedsQL)	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Perceived Stress Scale (PSS)	18 months
Self-Efficacy for Diabetes Scale	18 months
Children's Depression Inventory	18 months
Self-Perception Profile for Adolescents	18 months
Responses to Stress Questionaire (RSQ)	18 months
Diabetes Family Behavior Scale	18 months
Self Management of Type 1 Diabetes	18 months
Diabetes Conflict	18 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Margaret Grey, DrPh, FAAN, CPNP, Yale School of Nursing; Principal Investigator: Robin Whittemore, PhD, APRN, Yale School of Nursing

Publications and helpful links

General Publications

• Grey M, Boland EA, Davidson M, Li J, Tamborlane WV. Coping skills training for youth with diabetes mellitus has long-lasting effects on metabolic control and quality of life. J Pediatr. 2000 Jul;137(1):107-13. doi: 10.1067/mpd.2000.106568.
• Grey M, Boland EA, Davidson M, Yu C, Sullivan-Bolyai S, Tamborlane WV. Short-term effects of coping skills training as adjunct to intensive therapy in adolescents. Diabetes Care. 1998 Jun;21(6):902-8. doi: 10.2337/diacare.21.6.902.
• Whittemore R, Grey M, Lindemann E, Ambrosino J, Jaser S. Development of an Internet coping skills training program for teenagers with type 1 diabetes. Comput Inform Nurs. 2010 Mar-Apr;28(2):103-11. doi: 10.1097/NCN.0b013e3181cd8199.
• Grey M, Whittemore R, Liberti L, Delamater A, Murphy K, Faulkner MS. A comparison of two internet programs for adolescents with type 1 diabetes: design and methods. Contemp Clin Trials. 2012 Jul;33(4):769-76. doi: 10.1016/j.cct.2012.03.012. Epub 2012 Mar 29.
• Jaser SS, Whittemore R, Chao A, Jeon S, Faulkner MS, Grey M. Mediators of 12-month outcomes of two Internet interventions for youth with type 1 diabetes. J Pediatr Psychol. 2014 Apr;39(3):306-15. doi: 10.1093/jpepsy/jst081. Epub 2013 Oct 26.
• Grey M, Whittemore R, Jeon S, Murphy K, Faulkner MS, Delamater A; TeenCope Study Group. Internet psycho-education programs improve outcomes in youth with type 1 diabetes. Diabetes Care. 2013 Sep;36(9):2475-82. doi: 10.2337/dc12-2199. Epub 2013 Apr 11.
• Whittemore R, Jaser SS, Jeon S, Liberti L, Delamater A, Murphy K, Faulkner MS, Grey M. An internet coping skills training program for youth with type 1 diabetes: six-month outcomes. Nurs Res. 2012 Nov-Dec;61(6):395-404. doi: 10.1097/NNR.0b013e3182690a29.
• Jaser SS, Faulkner MS, Whittemore R, Jeon S, Murphy K, Delamater A, Grey M. Coping, self-management, and adaptation in adolescents with type 1 diabetes. Ann Behav Med. 2012 Jun;43(3):311-9. doi: 10.1007/s12160-012-9343-z.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: May 21, 2008
• First Submitted That Met QC Criteria: May 22, 2008
• First Posted (ESTIMATE): May 26, 2008

Study Record Updates

• Last Update Posted (ACTUAL): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Type 1 Diabetes; Adolescence; Children and Teenagers; Coping with Chronic Illness; Internet psychosocial program; Coping Skills Training
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 0711003291; R01NR004009 (NIH)